Henry Ford Health System 153270 - Coor- Clinical Research- Full time/w full time benefits in Detroit, Michigan
Under the supervision of the Principal Investigator (PI)/Investigator (I), and following established policies and procedures, performs a variety of scientific, clinical research activities, and participates in carrying out research objectives, ensuring compliance with all legal, regulatory and protocol guidelines. Provides methodological and technical support to the PI/I and serves as a liaison between the institution and the sponsor. Researches literature in the field.
PRINCIPAL DUTIES AND RESPONSIBILITIES:
Coordinate research projects and carries-out the objectives of the study under the direction of the PI/I following the specific study requirements, ensuring compliance with all legal, regulatory and protocol guidelines. Demonstrate compliance with Good Clinical Practice and the Code of Federal Regulations.
Implement established quality measures to assure compliance.
May coordinate efforts from various departments to ensure the central submission of materials supporting clinical research studies.
Collect study data for the analysis and interpretation of test results.
May perform statistical analysis related to the protocol.
Update and Maintain databases in support of clinical research.
Under PI/I oversight, may interpret the study data, including adverse events and response to drug, if applicable, to determine if the patient remains in the study.
May recruit and obtain informed consent from patients and control subjects that meet enrollment parameters, adhering to HIPAA laws.
Maintain related clinical research documents (i.e. case report forms, IRB information, adverse events, protocol changes, drug dispensing logs, regulatory binders, source documents)
May order and maintain study specific materials such as supplies and drugs. Maintain logs per study protocol.
May collect, process, package, store and ship specimens as required.
May perform study specific tasks such as monitoring vital signs, weight, ECG’s, phlebotomy, etc.
Under the direction of the PI/I, prepares protocol submissions, renewals, planned change forms, amendments, and final reports to the Institutional Review Board.
Keep abreast of new techniques and review literature in field pertinent to the area of research.
May assist in the writing papers for publications and scientific presentations.
Bachelor of Science degree from an accredited college or university in clinical research, biology, chemistry, nursing, psychology, or closely related field.
A Master's degree can be utilized in this position.
Requires a working knowledge of computer applications.
A working knowledge of research methodology, medical terminology and statistics preferred.
Henry Ford Health System, one of the largest and most comprehensive integrated U.S. health
care systems, is a national leader in clinical care, research and education. The system includes
the 1,200-member Henry Ford Medical Group, five hospitals, Health Alliance Plan (a health
insurance and wellness company), Henry Ford Physician Network, a 150-site ambulatory
network and many other health-related entities throughout southeast Michigan, providing a
full continuum of care. In 2015, Henry Ford provided $299 million in uncompensated care.
The health system also is a major economic driver in Michigan and employs more than 24,600
employees. Henry Ford is a 2011Malcolm Baldrige National Quality Award recipient. The
health system is led by President and CEO Wright Lassiter III. To learn more, visitHenryFord.com.
Whether it's offering a new medical option, helping you make healthier lifestyle choices or
making the employee enrollment selection experience easier, it's all about choice. Henry
Ford Health System has a new approach for its employee benefits program - My Choice
Rewards. My Choice Rewards is a program as diverse as the people it serves. There are
dozens of options for all of our employees including compensation, benefits, work/life balance
and learning - options that enhance your career and add value to your personal life. As an
employee you are provided access to Retirement Programs, an Employee Assistance Program
(Henry Ford Enhanced), Tuition Reimbursement, Paid Time Off, Employee Health and Wellness
and access to day care services at Bright Horizons Midtown Detroit, and a whole host of other
benefits and services. Employee's classified as contingent status are not eligible for benefits.
Equal Employment Opportunity/Affirmative Action EmployerEqual Employment Opportunity / Affirmative Action Employer Henry Ford Health System is committed to the hiring, advancement and fair treatment of all individuals without regard to race, color, creed, religion, age, sex, national origin, disability, veteran status, size, height, weight, marital status, family status, gender identity, sexual orientation, and genetic information, or any other protected status in accordance with applicable federal and state laws.